Plain English Summary
Background and study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this study is to test the performance of the masked FreeStyle Libre Flash Glucose Monitoring System with and without a potential In-Reader correction, a device designed for people with diabetes to monitor their blood sugar.
Who can participate?
Patients aged 18 and over with type 1 or 2 diabetes
What does the study involve?
Participants wear two masked (blinded) sensors for up to 14 days and take at least four fingerstick blood sugar readings per day whilst wearing the sensors. Participants attend up to six visits at the clinical study site, three of the visits consist of up to 8 hours blood sampling at regular intervals.
What are the possible benefits and risks of participating?
There may be no direct benefit to the participant. The only risks of participating in this study are associated with blood sample collection. These are small but could include pain, bruising, local infection and fainting.
Where is the study run from?
BioKinetic Europe (UK)
When is the study starting and how long is it expected to run for?
September 2017 to March 2018
Who is funding the study?
Abbott Diabetes Care Ltd (UK)
Who is the main contact?
Dr Pamela Reid
Effectiveness of a potential in-reader correction for FreeStyle Libre flash sensor glucose data
Assess the accuracy of the FreeStyle Libre Flash Glucose Monitoring System measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction.
Health and Social Care Research Ethics Committee A (HSC REC A), 11/09/2017, REC ref: 17/NI/0156; IRAS Project ID: 230816
Prospective single-arm trial
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Participants will wear two masked sensors for a period of up to 14 days. They will be requested to obtain at least four fingerstick readings per day whilst wearing the sensors (using the built-in test strip port in one of the study readers). Participants will have three in-clinic visits; each in-clinic visit will consist of eight hours of reference sampling at 15 minute intervals, from an IV port.
Primary outcome measures
The point accuracy of the FreeStyle Libre Flash Glucose Monitoring System, measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction. Measured on days 1, 2, 5, 7, 11 and 14 of sensor wear.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Aged 18 years or over
2. Type 1 or type 2 diabetes requiring insulin therapy for at least 6 months prior to enrolment
3. Participant reports self-testing their blood glucose levels at least twice per day
4. Suitable venous access for study participation
Target number of participants
Approximately 27 participants will be recruited
Participant exclusion criteria
1. Have a known allergy to medical grade adhesive
2. Be pregnant or planning to become pregnant within the study duration
3. Have skin abnormality at the application sites
4. Have a pacemaker or any other neurostimulators
5. Have concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff
6. Have anaemia
7. Currently participating in another clinical study
8. Participant is unsuitable for participation due to any other cause as determined by the Investigator
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Trial participating centre
MAC Research Ltd
Abbott Diabetes Care
Funding Body Type
private sector organisation
Funding Body Subtype
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal or conference presentation. Publication date January 2019.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from ADC_Witney_ClinicalAffairs@abbott.com.
Intention to publish date
Participant level data
Available on request
Results - basic reporting